Collection of Samples USOPTIVAL Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-84
SponsorUniversal Diagnostics
About this trial
A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must be 45-84 years of age.
Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.
Able to comprehend, sign, and date the written informed consent document.
Must be 45-84 years of age.
Disqualifiers
Subjects with positive FIT Test results in the 6 months preceding enrollment.
Subject has a current diagnosis of cancer.
Subject has a personal history of aerodigestive or digestive tract cancers.
Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
Trial population
Two cohorts of patients aged between 45 and 84, who have a suspected advanced adenoma or have been newly diagnosed with CRC, still not resected and scheduled for surgery, and patients who are at average risk of developing colorectal cancer, scheduled for a standard-of-care screening colonoscopy. Subjects will be considered enrolled after understanding and signing the ICF and a determination is made by the Investigator that the subject is eligible to participate according to the inclusion/exclusion criteria. Enrollment will be stopped when a sufficient number of confirmed cases of colorectal cancer, advanced adenomas, and matching control subjects have been enrolled. Under the current assumptions, 1,200 subjects will need to be enrolled.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Diagnostic testEvaluate the performance of a preliminary panel of biomarkers
Treatment groups
1,300 Participants
are divided into 2 treatment groupsGroup A: Arm A.1 intervention
Group B: Arm B1 intervention
Trial outcomes
Primary outcomes
1
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing
Samples Collected for Testing
Time frame
Within 12 months of sample collectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov